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Early Prevention of Childhood Obesity: an Active Pregnancy

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ClinicalTrials.gov Identifier: NCT02109588
Recruitment Status : Recruiting
First Posted : April 10, 2014
Last Update Posted : November 14, 2014
Sponsor:
Information provided by (Responsible Party):
María Perales Santaella, Technical University of Madrid

Brief Summary:
The main aim of this study was to examine the effect of a supervised physical exercise program on the prevention of childhood obesity and its impact on the motor development of the offspring.

Condition or disease Intervention/treatment
Pregnancy Behavioral: A supervised physical exercise program

Detailed Description:
The environment where the fetus growths up is essential for the risk of developing some diseases in later life, such as obesity. Exercise has showed being useful in the prevention on excessive maternal weight gain which is linked to fetus weight.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Early Prevention of Childhood Obesity: an Active Pregnancy
Study Start Date : March 2014
Primary Completion Date : August 2014
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control
Sedentary pregnant women
Experimental: Exercise group

Supervised physical conditioning program of three 55—60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training

Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60% of heart rate reserve. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate

Behavioral: A supervised physical exercise program

Supervised physical conditioning program of three 55—60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training

Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60% of heart rate reserve. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate




Primary Outcome Measures :
  1. Body mass index of the offsprings [ Time Frame: 0-24 postpartum months ]
    Body mass index was measured several times from 0 to 24 months

  2. Fetus body composition [ Time Frame: 0-24 postpartum months ]
    Fetus body composition (percentage of fat) was measured several times from 0 to 24 months

  3. Change from baseline in Maternal gestational weight gain [ Time Frame: 40-42 weeks of gestation ]
    Maternal weight gain during pregnancy

  4. Changes in Baby motor development [ Time Frame: 0-24 postpartum months ]
    Baby motor development was measured after delivery

  5. Recovery time to pre-gestational weight [ Time Frame: 6-12 postpartum months ]
    The time needed to recovery the pre-gestational weight was assessed.

  6. Glycemia level of the offsprings [ Time Frame: 0-24 postpartum months ]
    Glycemia level of the offsprings was measured until 24 months

  7. Postpartum depression [ Time Frame: 0-12 postpartum months ]
    The level of maternal depression was measured after delivery

  8. Change from baseline in Body image satisfaction [ Time Frame: up to 36 weeks ]
    Body image satisfaction was measured during and after pregnancy

  9. Changes from baseline in maternal quality of life [ Time Frame: up to 36 weeks ]
    Maternal quality of life was measured during and after pregnancy

  10. Placenta measurements [ Time Frame: At delivery ]
    Placenta measurements were collected at labor


Secondary Outcome Measures :
  1. Maternal outcomes [ Time Frame: At delivery ]
    Type of labor, stage of labor and some other maternal variables were measured at delivery

  2. Control of physical activity [ Time Frame: up to 10 weeks ]
    Control the level of physical activity during and after pregnancy

  3. Changes from delivery in Health of the offspring [ Time Frame: 0-24 postpartum months ]
    Health of the baby included the measurement of other variables such as blood pressure and cholesterol of the offsprings until 24 months

  4. Fetus outcomes [ Time Frame: At delivery ]
    Fetus outcomes were measured at delivery: Apgar score, PH umbilical cord, size and height of the baby, head circumference



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
  • Being able to communicate in spanish
  • Giving birth at Hospital Universitario de Torrejón, hospital Universitario de Puerta de Hierro and Hospital Universitario Severo Ochoa (Madrid).

Exclusion Criteria:

  • Multiparity
  • Obstetrician complications
  • Being interested in the study after 16 weeks
  • Not being regular in physical exercise program
  • Younger than 18 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02109588


Contacts
Contact: Maria Perales Santaella, PhD student 913364081 m.perales.santaella@gmail.com
Contact: Rubén Barakat, PhD 913364120 barakatruben@gmail.com

Locations
Spain
Universidad Politécnica de Madrid Recruiting
Madrid, Spain, 28040
Contact: María Perales Santaella, PhD student    913364081    m.perales.santaella@gmail.com   
Contact: Rubén Barakat, PhD    913364120    barakatruben@gmail.com   
Sponsors and Collaborators
Technical University of Madrid
Investigators
Study Director: Rubén Barakat, PhD Universidad Politécnica de Madrid

Responsible Party: María Perales Santaella, PhD student, Technical University of Madrid
ClinicalTrials.gov Identifier: NCT02109588     History of Changes
Other Study ID Numbers: Prevention childhood obesity
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: October 2013

Additional relevant MeSH terms:
Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms